Director – Capital Equipment Manufacturing Engineering

Director – Capital Equipment Manufacturing Engineering

Requirements

• Bachelor’s degree in engineering discipline
• Minimum 7 years experience in the Medical Device industry
• Minimum 5 years experience in Operations and managing engineering disciplines in medical device or highly regulated industry
• Minimum 3 years experience in production or manufacturing engineering of Capital Equipment
• Strong knowledge for cGMPs is essential
• Demonstrated understanding of applicable FDA and ISO standards
• Excellent oral and written communication skills
• Strong organizational skills and project management capabilities
• Demonstrated leadership skills in building cross-functional collaboration
• Ability to handle multiple tasks simultaneously and deliver to customer’s needs and on time
• People management skills including interviewing, hiring and training employees, delivering rewards and recognition as well as all aspects of performance management
• Competency with Microsoft Word, Excel, Powerpoint and ability to learn any other software packages as needed for operations management or performing with the broader Procept business
• Ability to travel to suppliers or additional Procept facilities as needed
• This position requires a full-time commitment to be present at a Procept facility
• Remote or hybrid work is not allowed.

Responsibilities

• Lead the new product introduction manufacturing engineering team and function for capital equipment
• Build strong relationships with R&D, Quality, Supply Chain and Regulatory functions
• Lead the sustaining engineering function for capital equipment
• Expertise in managing a dynamic workload, define and implement cost improvements, work with production leads to assure operator safety, management of NCMR and CAPA, maximize yield and always assure continuity of production to established plans and targets
• Partner with the disposable business operations team to define and align common best practices as well as needed differentiation points for a low volume, high-cost durable equipment
• Determine group priorities and vision. Establish a strong cadence of completing the most important initiatives to plan and relentlessly prevent nonvalue added work from entering the program queue
• Implement continuous improvement structure and excellence to maximize first pass yield, optimize reliability improvements, institute a balance of programs to reduce cost and increase velocity
• Hire, lead and mentor the capital equipment operations team
• Create and operate to a defined budget (expense, capital and resource) that accomplishes the company goals in a responsible and efficient manner to ultimately maximize product margin
• Assure all work is performed in compliance with FDA and international standards as well as Procept documented practices.

Preferred Qualifications

• Master’s degree in engineering or engineering management
• Experience working with production of a robotic or complex electromechanical system
• Certification in Lean Six Sigma